Vaxelis is a combination vaccine that protects children against six diseases in a single shot: diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and Haemophilus influenzae type b (Hib). The FDA approved it in December 2018 for use in children from 6 weeks through 4 years of age. Because it rolls six vaccines into one injection, Vaxelis reduces the total number of shots a child needs during their first two years of life.
Six Diseases in One Shot
Before combination vaccines, protecting a child against these six infections meant separate injections at each visit. Vaxelis combines them into a single dose, which is why it’s called a hexavalent vaccine. The six diseases it targets are serious and, in some cases, life-threatening for infants:
- Diphtheria can cause a thick coating in the throat that leads to breathing problems, heart failure, and paralysis.
- Tetanus causes painful muscle stiffness and lockjaw, triggered by bacteria that enter through cuts or wounds.
- Pertussis (whooping cough) produces violent coughing fits that can be dangerous or fatal in very young babies.
- Polio can cause permanent paralysis and was once one of the most feared childhood diseases.
- Hepatitis B is a liver infection that can become chronic and lead to liver damage or cancer later in life.
- Hib disease causes meningitis, pneumonia, and other invasive infections, primarily in children under 5.
What’s Inside the Vaccine
Each dose of Vaxelis contains inactivated or modified versions of the organisms that cause these six diseases. None of them can cause the actual infections. The pertussis component is acellular, meaning it uses purified proteins from the pertussis bacterium rather than whole killed bacteria. This approach is associated with fewer side effects than older whole-cell pertussis vaccines.
The polio component uses inactivated (killed) poliovirus covering all three types. The Hib component works by linking a piece of the Hib bacterium’s outer coating to a carrier protein, which helps a baby’s developing immune system recognize and respond to it effectively. The hepatitis B portion contains a surface protein from the virus that trains the immune system without any risk of infection.
Dosing Schedule and Age Range
Vaxelis is given as a three-dose series, with each dose administered at a separate well-child visit. It is approved for children starting at 6 weeks of age and can be given up to the child’s 5th birthday. The three doses typically align with the routine immunization visits at 2, 4, and 6 months of age, fitting neatly into the standard childhood vaccination schedule.
Because Vaxelis covers the same diseases as several individual vaccines (DTaP, IPV, Hib, and hepatitis B), using it can reduce the number of injections a child receives at a single appointment. A baby who would otherwise get three or four separate shots at their 2-month visit might receive fewer with Vaxelis in the mix. It’s worth noting that Vaxelis only covers three of the recommended DTaP doses. Children still need a fourth and fifth dose of DTaP at later ages, given as separate vaccines.
How Well It Works
Clinical trials showed strong immune responses across all six components. One month after the third dose, about 97% of children in the Vaxelis group developed protective antibody levels against Hib, and roughly 85% reached the higher threshold associated with long-term protection. For hepatitis B, the results were even more striking: over 99% of children achieved protective antibody levels.
These response rates were comparable to, and in some cases higher than, children who received the standard separate vaccines. The trial data supported the conclusion that combining six antigens into one shot does not weaken the immune response to any individual component.
Common Side Effects
The side effects of Vaxelis are similar to what parents typically see with any infant vaccination. The most common reactions include fussiness, soreness or redness at the injection site, drowsiness, and decreased appetite. Some children develop a mild fever. These reactions generally appear within a day or two of the shot and resolve on their own within 48 to 72 hours.
Because Vaxelis contains multiple antigens, parents sometimes worry it could overwhelm a baby’s immune system. In practice, the immune system handles the combination without difficulty. Babies encounter thousands of foreign substances daily, and the antigens in a hexavalent vaccine represent a tiny fraction of what their immune systems process routinely.
Who Should Not Receive Vaxelis
Children who have had a severe allergic reaction to a previous dose of any vaccine containing diphtheria, tetanus, pertussis, polio, hepatitis B, or Hib components should not receive Vaxelis. The same applies to children with a known allergy to any ingredient in the vaccine. Children who experienced a brain-related complication (such as prolonged seizures or loss of consciousness) within seven days of a prior pertussis-containing vaccine are also not candidates.
Vaxelis is not approved for children younger than 6 weeks or for anyone 5 years of age and older. It is also not used as a birth dose of hepatitis B. Newborns still receive their first hepatitis B shot separately, typically within 24 hours of birth, before the Vaxelis series begins.
How Vaxelis Compares to Other Vaccines
Before Vaxelis, the closest available option in the U.S. was Pediarix, which combines DTaP, polio, and hepatitis B but does not include Hib. That meant children still needed a separate Hib injection at the same visit. Vaxelis adds the Hib component, consolidating one more vaccine into the combination and potentially eliminating an additional needle stick per visit.
Vaxelis can generally be used interchangeably with other brands of the individual component vaccines. If a child started their series with a different DTaP or Hib product, Vaxelis can typically be used for subsequent doses. This flexibility makes it practical for clinics that stock different vaccine brands or for families who switch providers.